NCT03517293: ENHANCED

Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally

Completed NA Last updated 8 August 2023

What this trial tests

NA trial testing Aerobic Exercise training in Physical Exercise in 133 participants. Completed in 30 January 2023.

Timeline

1 July 2015

Primary endpoint
30 January 2023

30 January 2023

Quick facts

Lead sponsor	East Carolina University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	133
Start date	1 July 2015
Primary completion	30 January 2023
Estimated completion	30 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Aerobic Exercise training

Conditions studied

• Physical Exercise — all drugs for Physical Exercise →

Sponsor

East Carolina University

Who can join

Adults 18 to 35, female only, with Physical Exercise. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

AHA and ACSM recognize lack of exercise is a major risk factor for developing cardiovascular disease (CVD), and other CVD risk factors such as obesity. It is important to note that CVD is the sixth leading cause of death and children are more likely to be undiagnosed due to their age and lack of symptoms. Further, according to the CDC, over one-third of children and adolescents are overweight or obese and at increased risk of CVD. Although many programs for children aim to decrease CVD risks and obesity few, if any, programs begin the intervention during prenatal development. Our preliminary findings suggest that regular maternal exercise improves cardiovascular health (lower heart rate, increased heart rate variability), normalizes body fat composition, and improves nervous system and motor tone even after birth. Norepinephrine is essential for fetal development, influences many tissues (heart, nerve cells, skeletal muscle, and fat cells), and can stimulate growth factors. It is believed that exercise hormones, such as norepinephrine, released during maternal exercise influence these growth factors during development.

The central hypothesis of this proposal is that regular maternal exercise during pregnancy will improve the health of offspring before and after birth as evidenced by lower resting heart rate, increasing heart rate variability improved neurological maturation, and decreased adiposity. We have three specific aims to test this hypothesis through the Enhanced Neonatal Health and Neonatal Cardiovascular Efficiency Developmentally (ENHANCED) by Mom project (IRB approved #12-002524). Aim 1 will establish the association between maternal exercise during pregnancy and the heart health of offspring before and after birth. Aim 2 will determine the relationship between modes of regular maternal exercise and neonate neurological and muscular maturation as this relates to health of the child after birth. Aim 3 will elucidate the influence of different modes of maternal exercise during pregnancy on fetal and infant body composition as this relates to risk of obesity and CVD disease. These studies will provide novel insight into how different types of maternal exercise during pregnancy influence the overall health of offspring. Furthermore, these findings may have significant implications on the public health as it may provide evidence of pregnancy as the earliest intervention for attenuating cardiovascular disease risk of children.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Maternal Exercise Modes on Glucose and Lipid Metabolism in Offspring Stem Cells.
   Jevtovic F, Zheng D, Houmard JA, Krassovskaia PM, et al · · 2023 · cited 29× · PMID 36722208 · DOI 10.1210/clinem/dgad059
2. Moderate intensity aerobic exercise during pregnancy and 1-month infant Morphometry.
   McDonald SM, Isler C, Haven K, Newton E, et al · · 2021 · cited 15× · PMID 33522701 · DOI 10.1002/bdr2.1671
3. Influence of maternal aerobic exercise during pregnancy on fetal cardiac function and outflow.
   May LE, McDonald S, Forbes L, Jones R, et al · · 2020 · cited 13× · PMID 33345961 · DOI 10.1016/j.ajogmf.2020.100095
4. Differences in substrate metabolism between African American and Caucasian infants: evidence from mesenchymal stem cells.
   Jevtovic F, Lopez CA, Zheng D, Cortright RN, et al · · 2023 · cited 12× · PMID 37055039 · DOI 10.1152/japplphysiol.00737.2022
5. Influence of Maternal Exercise on Glucose and Lipid Metabolism in Offspring Stem Cells: ENHANCED by Mom.
   Chaves A, Weyrauch LA, Zheng D, Biagioni EM, et al · · 2022 · cited 12× · PMID 35511592 · DOI 10.1210/clinem/dgac270
6. The influence of exercise during pregnancy on racial/ethnic health disparities and birth outcomes.
   Raper MJ, McDonald S, Johnston C, Isler C, et al · · 2021 · cited 11× · PMID 33771102 · DOI 10.1186/s12884-021-03717-5
7. Influence of Supervised Maternal Aerobic Exercise during Pregnancy on 1-Month-Old Neonatal Cardiac Function and Outflow: A Pilot Study.
   May LE, McDonald S, Stewart C, Newton E, et al · · 2023 · cited 10× · PMID 37259255 · DOI 10.1249/mss.0000000000003227
8. Exercise FITT-V during pregnancy: Association with birth outcomes.
   Claiborne A, Wisseman B, Kern K, Steen D, et al · · 2024 · cited 8× · PMID 38659157 · DOI 10.1002/bdr2.2340